Endoscopic biopsy device with no moving parts

ABSTRACT

A biopsy device includes an elongate tube comprising a distal end, a proximal end, and a lumen. The biopsy device further includes a cutting member disposed in an opening of the distal end of the elongate tube, the cutting member being immovable relative to the elongate tube. The cutting member comprises a blunting surface that faces outward from the elongate tube, and a hollow truncated cone having a truncated end comprising a cutting surface that maintains a fixed radial distance from the elongate tube and that faces into the elongate tube and away from the distal end of the elongate tube, wherein the cutting surface has a contiguous perimeter, and wherein the truncated end is angled relative to a longitudinal axis of the elongate tube such that the cutting member has a shape of a right circular hollow cone or an oblique oval hollow cone.

RELATED APPLICATIONS

The present application is a continuation of U.S patent application Ser.No. 16/793,511, filed Apr. 29, 2020, which is incorporated by referenceherein.

TECHNICAL FIELD

The embodiment relates generally to medical biopsy devices. Moreparticularly, the embodiment pertains to devices for endoscopic biopsy.

BACKGROUND

The following is a tabulation of some prior art that presently appearsrelevant:

Patent Number Kind Code Issue Date Patentee  8882680 B2 Nov. 11, 2014Furlong 10231715 B2 Mar. 19, 2019 Quick

Endoscopy is often performed to obtain tissue samples to aid in thediagnosis of, screening for, and monitoring of, disease conditions. Thestructure of the luminal surface of viscera is composed of a mucosalsurface layer composed of glandular cells, and beneath it, a submucosallayer composed of weak connective tissue. This tissue plane allowsmucosal samples to be separated from the submucosa with little force anddistortion.

Mucosal samples are collected to determine the distribution, location,and severity of disease activity by microscopic examination. It isimportant that the samples be collected intact and of sufficient size,to preserve microscopic structural detail. It is also important tosegregate collected samples in order to preserve information as to thelocation from which the samples were removed.

Presently, samples are retrieved by withdrawal of the entire biopsydevice from the endoscope and the samples then transferred to separateindividually labelled receptacles for transport for preparation formicroscopic examination. this biopsy process is limited to a smallnumber of samples per repetition. Where multiple biopsies are taken frommultiple sites, this can be a time-consuming process. In some cases,forty or more samples are required. Commonly used biopsy forceps allowtwo samples to be taken per repetition, thus requiring twenty passes ofthe forceps. Each repetition takes one minute. This adds twenty minutesto the procedure and sedation time, increasing costs and risk.

Existing biopsy devices utilize movable cutting surfaces, such asopposing surfaces or a rotating cutting surface, requiring an actuatingmechanism, which complicates construction and increases risk of failurewith repeated use. U.S. Pat. No. 8,882,680 (2014) uses a complex rotarysystem to debride a polyp and return the sample though suction. It doesnot, however, preserve the histologic architecture of the sample,instead reducing it to “cytological sawdust”. U.S. Pat. No. 10,231,715(2019) uses a rotatable blade inserted into the tissue. Vacuum ismentioned as a means of transporting samples externally, but is not anintegral feature of its function.

SUMMARY

An embodiment of an endoscopic biopsy device for collection multiplesamples without removal of the device, wherein the device comprises anelongate tube having in an axial direction a distal end and a proximalend; a cutting element affixed within the distal end; and a suctionvalve affixed to the proximal end.

The tube is of sufficient diameter, length, composition, and flexibilityto be introduced into and through an instrument channel of an endoscope,and protrude from a distal end of the endoscope. The tube has a lumen ofsufficient diameter to accept the disposition of the cutting element, toallow transmission of suction from the suction valve, and to provide forpassage of a specimen proximally.

The cutting element is a hollow cone having a distal base end and aproximal truncated end and is of sufficient diameter to be disposedwithin the lumen of the tube. The truncation may be angled, andtherefore may be circular or oval. The truncated end possesses a bevelededge and may be manufactured by stamping, casting, milling, ordepositing material capable of retaining a sharp edge. The proximaltruncated end is disposed axially within the lumen of the distal end ofthe tube. The distal base of the cutting element possesses a flange ofsufficient size to be affixed onto the distal end of the tube. Theflange may be angled, and therefore may be circular or oval.

The valve has a conduit with a distal end that is contiguous with thelumen of the proximal end of the tube and a proximal end that may beconnected to a suction source.

The suction source may be that of an endoscope or a separate suctiondevice. The conduit has a fenestration open to the ambient air.

Method for taking a tissue specimen using the device, the methodcomprising the steps of:

-   -   (a) inserting the distal end of the device into the instrument        channel of the endoscope and slidably translating the proximal        end of the device into the instrument channel until the distal        end of the device appears in the visual field of the endoscope;    -   (b) positioning the distal end of the device to a selected        sampling site by deploying the distal portion of the tube to        contact the sampling site by translating the proximal portion of        the tube, by maneuvering the endoscope, or by both;    -   (c) occluding the fenestration of the valve, suction causing a        specimen to be drawn into the distal end of the device and        traversing the proximal end of the cutting element;    -   (d) Withdrawing the proximal end of the tube a short distance,        causing the distal end of the tube to be translated away from        the sampling site, the cutting element transecting the specimen,        and the distal end of the device, no longer being in contact        with the sampling site, permits suction to cause the specimen to        be drawn through the lumen of the tube to an external collection        device interposed between the valve and the suction source;    -   (e) un-occluding the fenestration.

Method for taking subsequent specimens further comprising the steps of:

-   -   (f) selecting a further sampling site;    -   (g) repeating steps (b)-(e) until the required number of        specimens is collected.

Thus a large number of specimens can be collected and segregatedefficiently without removing the device from the endoscope, reducingprocedure and anesthesia time.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrated embodiments of the present invention are described hereinwith reference to the accompanying drawings, in which:

FIG. 1 is a perspective detail view of one embodiment of a proximalportion of a biopsy device positioned between the instrument channel andsuction channel of an endoscope.

FIG. 2 is a perspective detail view of a distal portion of a biopsydevice protruding from the instrument channel of the distal end of anendoscope.

FIG. 3 is a front perspective view of one embodiment of a cuttingelement.

FIG. 3A is a front orthogonal view of FIG. 3.

FIG. 3B is a left orthogonal view of FIG. 3.

FIG. 3C is a rear perspective view of FIG. 3.

FIG. 3D is a cross sectional view of FIG. 3B.

FIG. 4 is a left orthogonal view of a distal portion of a biopsy device.

FIG. 5 is a left orthogonal view of an embodiment of a valve.

FIG. 6 is an exploded left orthogonal view of a distal portion of abiopsy device.

FIG. 7 is an assembled view of FIG. 6.

FIG. 8 is a view of one embodiment of a valve.

FIG. 9 is another embodiment of a valve

FIG. 9A is a left orthogonal view of FIG. 9.

FIG. 10 is a solid perspective view of FIG. 5.

FIG. 10A is a solid cutaway view of FIG. 10.

FIG. 11 is a solid orthogonal cutaway view of FIG. 7.

FIG. 11A is a close up view of area indicated in FIG. 11.

FIG. 12 is a cutaway view of how the element engages a specimen.

FIG. 13 is a perspective detail view of another embodiment of theproximal portion of a biopsy device positioned between the instrumentchannel and an external suction device (not shown).

DETAILED DESCRIPTION

It would be advantageous to provide a biopsy device of simpleconstruction and without moveable parts that permits the resection ofintact specimens and is able to transport the specimens to an externalcollection device without the need to remove the biopsy device from theendoscope. A large number of samples could therefore be obtained in ashort period, reducing procedure time and and anesthesia risk.

FIG. 1 illustrates an embodiment of a biopsy device (50) as it is to beused. The proximal end (52) of the tube (51) is situated in theinstrument port (101) of an endoscope handle (100). Suction valve (55)occupies the suction port (102) of the endoscope (100). Proximal end(52) may be slidably translated to position the device (50).

FIG. 2 illustrates the distal end of the tube (53) projecting from thedistal end of the endoscope (103). Cutting element (54) is disposedwithin the distal end of the tube (53) and may be placed in contact witha potential sampling site.

Cutting element (54) may be manufactured by stamping, casting, milling,or depositing material capable of retaining a sharp edge.

FIG. 3 shows details of cutting element (54) demonstrating the positionof flange (58) and cutting edge (59) .

FIG. 3A shows an axial view of the distal end of cutting element (54)

FIG. 3B shows a lateral view of cutting element (54)

FIG. 3C shows detail of the cutting edge (59)

FIG. 3D shows a cross sectional view of the interior of cutting element(54)

FIG. 4 shows detail of the disposition of cutting element (54) withindistal end of tube (53).

FIG. 5 shows detail of one embodiment of valve (55).

FIG. 6 shows an exploded view of distal end of the tube (53) showingcutting element (54) and catheter (51).

FIG. 7 shows the elements of FIG. 6 as assembled.

FIG. 8 shows detail of one embodiment of valve (55).

FIGS. 9 and 9A shows an alternative embodiment of valve (55A):

FIG. 10 shows a solid view of an embodiment of valve (55).

FIG. 10A shows s cross sectional view of FIG. 10.

FIG. 11 Illustrates a solid cross sectional view of the constructiondetails of distal end of the tube (53) and disposition of cuttingelement (54).

FIG. 11A Is a solid cross sectional close up detail of FIG. 11.

FIG. 12 is an illustration of the in which cutting edge (59) device ispositioned to transect a sample of the mucosa (200).

FIG. 13 illustrates another embodiment of the device as it is to beused. Valve (55 a) is attached to suction tubing (104) leading to asuction device (not shown).

OPERATION

The first embodiment of the device in FIG. 1 is introduced into theinstrument channel (101) of an endoscope with the valve (55) disposed inplace of the suction port (102). The catheter (51) is advanced until thedistal end (53) contacts the intended biopsy site. The fenestration (57)is covered by a finger, transmitting suction to the lumen of thecatheter (51), thereby drawing a tissue sample through cutting element(54). Withdrawal of the proximal end of the catheter (52) a shortdistance will cause cutting element (54) to transect the specimen.Suction will cause the specimen to be transported through the catheter(51) to a collection device.

Repetition of this operation will allow the collection of a multitude ofspecimens without withdrawal of the device.

An alternative embodiment differs from the first in that valve (55a)does not replace suction port (102), but instead is attached to aseparate suction and collection devices. Fenestration (57 a) is coveredby a finger, transmitting suction to the lumen of catheter (51)

The advantages of these embodiments are simplified construction,efficient specimen collection and shortened procedure time.

CONCLUSION

Endoscopic biopsy is an essential tool of medicine. It, however, entailscosts and risk. This embodiment, through its simplicity, has thecapability of reducing procedure time, anesthetic exposure, andmanufacturing cost, while at the same time increasing reliability.

While the above description contains many specificities, these shouldnot be construed as limitations on the scope, but rather anexemplification of one embodiment thereof. Other variations arepossible. For example, other embodiments may be adapted to use onaccessible tissues, independent of an endoscope, such as oral orgynecologic sites.

Accordingly, the scope should be determined not by the embodimentillustrated, but by the claims and their legal equivalents.

DRAWINGS—REFERENCE NUMERALS

50 Biopsy device

51 Tube

52 Proximal end of tube

53 Distal end of tube

54 Cutting element

55 Suction valve

55 a Suction valve

56 Conduit

57 Fenestration

58 Flange

59 Beveled cutting edge

100 Handle of endoscope

101 Instrument port of endoscope

102 Suction port of endoscope

103 Distal end of endoscope

104 Suction tubing

200 Mucosal layer

201 Submucosal layer

What is claimed is:
 1. An endoscopic biopsy device, comprising: anelongate tube comprising a distal end, a proximal end, and a lumenextending from the distal end to the proximal end; and a cutting memberdisposed in an opening of the distal end of the elongate tube, thecutting member being immovable relative to the elongate tube, whereinthe cutting member comprises: a hollow truncated cone having a truncatedend comprising a cutting surface that maintains a fixed radial distancefrom the elongate tube and that faces into the elongate tube and awayfrom the distal end of the elongate tube, wherein the cutting surfacehas a contiguous perimeter, and wherein the truncated end is angledrelative to a longitudinal axis of the elongate tube such that thecutting member has a shape of a right circular hollow cone or an obliqueoval hollow cone; and a blunting surface that faces outward from theelongate tube.
 2. The endoscopic biopsy device as recited in claim 1,wherein the elongate tube is of sufficient diameter, length,composition, and flexibility to be slidably disposed in an instrumentchannel of an endoscope and to extend from a distal end of theendoscope.
 3. The endoscopic biopsy device as recited claim 1, whereinthe truncated end of the cutting member comprises a beveled edge.
 4. Theendoscopic biopsy device as recited in claim 1, wherein the cuttingmember comprises a flange at a base thereof that comprises the bluntingsurface, wherein the flange is angled relative to the longitudinal axisof the elongate tube and has a circular or oval shape.
 5. The endoscopicbiopsy device as recited in claim 1, wherein the truncated end of thecutting member is disposed axially within the lumen at the distal end ofthe elongate tube.
 6. The endoscopic biopsy device as recited in claim1, further comprising: a flange attached to the distal end of theelongate tube.
 7. The endoscopic biopsy device as recited in claim 1,the cutting member having been manufactured by stamping, milling, ordepositing material capable of retaining a sharp edge for the cuttingsurface.
 8. The endoscopic biopsy device of claim 1, wherein: theelongate tube is configured to draw tissue of the body into the distalend of the elongate tube responsive to actuation of a valve; and thecutting member is configured to cut the tissue while the tissue is drawninto the distal end of the elongate tube to create a tissue sample. 9.The endoscopic biopsy device of claim 1, further comprising: a valvedisposed proximate to the proximal end of the elongate tube, whereinactuation of the valve causes suction to be applied within the elongatetube.
 10. The endoscopic biopsy device of claim 9, wherein the valve isopen to ambient air and attached to a suction device.
 11. The endoscopicbiopsy device of claim 9, wherein the valve is interposed between theproximal end of the elongate tube and a suction device.
 12. Theendoscopic biopsy device as recited in claim 9, wherein the valve isconstructed such that at least partially blocking an opening of thevalve transmits suction to the lumen of the elongate tube.
 13. Theendoscopic biopsy device of claim 9, wherein: the elongate tube isconfigured to draw tissue of the body into the distal end of theelongate tube responsive to the actuation of the valve; and the cuttingmember is configured to cut the tissue while the tissue is drawn intothe distal end of the elongate tube to create a tissue sample.
 14. Theendoscopic biopsy device of claim 1, wherein the endoscopic biopsydevice is configured to collect multiple tissue samples from a body andto transport the multiple tissue samples outside of the body withoutremoval of the endoscopic biopsy device from the body.
 15. A cuttingmember for a biopsy device, wherein: the cutting member is configuredfor insertion into an opening of a distal end of an elongate tube of thebiopsy device, wherein the cutting member is configured to be immovablerelative to the elongate tube; and the cutting member comprises: ahollow truncated cone having a truncated end comprising a cuttingsurface that maintains a fixed radial distance from the elongate tubeand that faces into the elongate tube and away from the distal end ofthe elongate tube, wherein the cutting surface has a contiguousperimeter, and wherein the truncated end is angled relative to alongitudinal axis of the elongate tube such that the cutting member hasa shape of a right circular hollow cone or an oblique oval hollow conewhile the cutting member is disposed in the opening of the distal end ofthe elongate tube; and a blunting surface that faces outward from theelongate tube.
 16. The cutting member of claim 15, wherein the truncatedend of the cutting member comprises a beveled edge.
 17. The cuttingmember of claim 15, wherein the cutting member comprises a flange at abase thereof that comprises the blunting surface, wherein the flange isconfigured to be angled relative to the longitudinal axis of theelongate tube and has a circular or oval shape.
 18. The cutting memberof claim 15, wherein the truncated end of the cutting member isconfigured to be disposed axially within the lumen at the distal end ofthe elongate tube.
 19. The cutting member of claim 15, the cuttingmember having been manufactured by stamping, milling, or depositingmaterial capable of retaining a sharp edge for the cutting surface. 20.The cutting member of claim 15, wherein the cutting member is a cuttingmember for an endoscopic biopsy device.